Board Member Retreat 2017 Informed Consent Exempt Categories Continuing Reviews Transition of Expedited Studies Single IRB QA/QI

Revised Common Rule (2018 Rule) 45 CFR 46 Effective date and compliance date for all but the single IRB provision in the Rule remains January 19, 2018. ***However, on October 7th, 2017, HHS requested a 1 year delay in the “general implementation date” of the Rule, while “allowing the use of three burden-reducing provisions during the delay year.” History of the Common Rule: First adopted in 1991 by 15 federal agencies. Have essentially remained unchanged since then. The process of revising the Rule began in 2011, with an Advanced Notice of Proposed Rulemaking, to request comments from the public and research community on how the then-current regs for protecting research participants might be modernized to be more effective. In September of 2015, HHS and 15 other federal departments and agencies published the NPRM, proposing revisions. In response to the NPRM, HHS received more than 2100 public comments, the majority of which were from people writing in their individual capacity. The proposals that received the most comments were those related to biospecimens (the expanded definition of human subjects to include de-identified biospecimens). On January 19, 2017 the final Rule was published. A note about terminology: pre-2018 and 2018 are terms we are trying to use!

Informed Consent

Revised Common Rule: Changes Related to Informed Consent Requirements regarding IC content and organization Required elements Broad consent is a new option Posting requirement for federally-funded clinical trials Waiver of ICP no longer required for screening/recruitment

Informed Consent Requirements a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research” Preamble specifies that this section must be organized in a way that “facilitates comprehension.” Requirement applies to all consents, except broad consents. Expectation is that this section will be “relatively short.” For some MR research, this may be the entire consent document. Info provided here need not be repeated in the body of the consent document. May provide clarification in future guidance.

Key Information The fact that consent is being sought for research and participation is voluntary The purposes of the research, expected duration of participation, study procedures Reasonably foreseeable risks Benefits Appropriate alternative procedures/treatments, if any See 45 CFR 46.116(a)(5)(i), Federal Register Vol. 82, No. 12, p7213-14 Preamble specifies that risks outlined here should be most important—e.g. those presented in a clinical setting.

Overview Study details Purpose of the research Voluntary Participation Benefits and Risks

Informed Consent Requirements: New Required Element Research involving collection of identifiable private information or identifiable biospecimens. One of two statements is required Identifiers might be removed and info or biospecimens could be used for future research without additional IC from the subject or LAR; OR A statement that subject’s info or biospecimens, even if identifiers are removed, will not be used or distributed for future research.

New Additional Elements: If applicable, the consent document must also now include A statement that the subject’s biospecimens, even if de-identified, may be used for commercial profit and whether the subject will share in any such profit. A statement regarding whether clinically relevant research results, including individual results, will be disclosed to subjects, and if so, under what conditions. Whether research involving biospecimens will or might include whole genome sequencing. See 45 CFR 46.116(b) and (c)

Informed Consent: Broad Consent Broad consent is an option for the storage, maintenance and secondary research use of identifiable private information/biospecimens. Permissible only for secondary research. If utilized, a waiver cannot be granted to allow study team to subvert a participant’s refusal to provide broad consent. If obtained, specific IC elements are required 116(d) See 45 CFR 46.116(a), (d) and (f)

Secondary Research with Biospecimens: Options available to researchers De-identify = Not human subjects research Code specimens Request waiver of ICP and HIPAA authorization (as under pre-2018 Common Rule) Obtain broad consent in initial encounter (research or non- research) to allow future/secondary use See 45 CFR 46.116(a), (d) and (f)

Informed Consent: Posting Requirement for Clinical Trials Rule’s definition of “clinical trial”: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control” to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.”

Posting Requirement Continued… Each clinical trial “conducted or supported by” a federal agency, one IRB-approved consent form must be posted . . . on a publicly available federal website. Timing: After the trial is closed to recruitment and no later than 60 days after the last study visit by any subject, as required by the protocol.

Informed Consent: Waivers If broad consent is obtained, the IRB cannot grant a waiver to allow the study team to conduct secondary research on identifiable private information or identifiable biospecimens. Waiver of informed consent process no longer required if identifiable private information or biospecimens will be obtained for screening or recruitment purposes. This applies to info obtained verbally as well as to identifiable info/biospecimens obtained by accessing records or a biorepository NOTE, however, that the Privacy Rule has not changed, so a partial waiver of HIPAA authorization is still required if PHI that will be collected or viewed as part of screening/recruitment!!! See 45 CFR 46.116(f) and (g)

New Exempt Categories 45 CRF 46.104 Weldon George, MPH IRB Manager

Exempt Category 1 Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Exempt Category 2 Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: i. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; ii. Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or iii. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by .111(a)(7).

Exempt Category 3 Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met: A. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; B. Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or C. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by .111(a)(7).

ii. For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. iii. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Exempt Category 4 Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: i. The identifiable private information or identifiable biospecimens are publicly available; ii. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;

iii. The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E [HIPAA], for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or iv. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Exempt 4 Summary Secondary research only Data/specimens can be both retrospective and prospective Four stand-alone qualifications (no interdependency) Data/specimens are publicly available Data is recorded such that subject identities cannot be readily ascertained and the investigator does not contact or re-identify subjects; or Data includes only identifiable health information protected under HIPAA; or The research is conducted by or on behalf of a Federal dept. or agency using gov’t data obtained for non-research reasons and, if identifiable, adheres to specified privacy standards

Exempt Category 5 Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

i. Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal website or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

Exempt Category 6

Exempt Category 7 –Brand New Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §__.111(a)(8).

New exemption to enable storage or maintenance of identifiable data/specimens for secondary research o Broad consent must be obtained (no waiver of consent is allowed but waivers of documentation of consent are unlikely but possible) o Limited IRB review is required for all research under this exemption

Exempt Category 8 Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met: i. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §__.116(a)(1) through (4), (a)(6), and (d); ii. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §__.117;

iii. An IRB conducts a limited IRB review and makes the determination iii. An IRB conducts a limited IRB review and makes the determination required by §__.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and iv.The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

References PRIM&R website

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Continuing Reviews Jamie Reddish, MPH

Continuing Reviews- Federal Regs. New subsection (f)(1) – Eliminates expedited CRs, if… Research is Expedited Limited IRB Review Study is in data analysis Follow-up is part of clinical care.

Pre-2018 Rule – Continuing Review Expedited CR Standard Constituting Review CR Lite/ Check-in Change to Exempt and close Chair

Chair: determines Exempt Cat. 4 Close Study CR Exp. Cat. 5 w/ HIPAA Chair: determines Exempt Cat. 4 Close Study CR Exp. Cat. 5 Chair: determines same category CR Lite/2018 Rule CR Ex. Cat. 8 Chair: continue full CR Regular CR/ Pre- 2018 Rule Provide rationale

Approval Letters Please note this protocol remains approved under the pre 2018 Rule and full continuing review will be required. OR Please note per the 2018 Rule this protocol is now Exempt and continuing reviews will no longer be required and your application will be closed per USF HRPP policy. Please note this protocol now qualifies for an Annual Check-in and traditional full continuing reviews are no longer required.

Continuing Review- Lite (2018 Rule)

Study Closure

Full Board Continuing Review No Change!

Single IRB Review: What’s it all about? Julie Moore, J.D., M.S. PA, CIP Associate Director Research Integrity & Compliance In spring 2016, the NIH released a new policy requiring all sites participating in NIH-funded human subjects research to use a single IRB (sIRB). The sIRB will be responsible for conducting the ethical review for all participating sites.

The Basics Reviewing IRB is responsible for the ethical review of research Local (relying, ceding) IRB retains responsibility for: Local context issues Providing oversight/ensuring compliance Negotiating reliance agreements Terminology: “Reviewing IRB” means the IRB that’s conducting the ethical review of the research. “Relying or ceding” institution means the institution/entity that has ceded ethical review.

Single IRB Review: Driving factors SMART IRB Reliance Initiative NIH Single IRB Policy Revised Common Rule 21st Century Cures Act 21st Century Cures Act, published December of 2016, requires government to reduce duplication of effort in human subject protections—deadline is December 13, 2019.

SMART IRB National Reliance Initiative USF signed on in April 2017 SMART IRB reliance agreement can serve as the master reliance agreement for multi-center studies when both the ceding institution and the reviewing IRB’s institution have signed the agreement. For more information about participating institutions, see the SMART IRB website. SMART Reliance Initiative: “Streamlined, Multisite Accelerated Resources for Trials.” Goal is to streamline and harmonize the IRB review process for multi-site studies, while ensuring appropriate protections for research participants. Funded by the National Center for Advancing Translational Sciences. Began in 2014 as a project called IRB Rely, which was led by Dartmouth—funded by NCATS through 2016. In July of 2016, NCATS funded the next phase of work to enable IRB reliance on a broader, national scale. SMART IRB is led by Harvard Catalyst, U. Wisc. and Dartmouth. Now has over 300 institutions signed on.

NIH Single IRB Policy: The Basics Effective date: January 25, 2018 Applies to all multi-site human subjects research regardless of funding mechanism (grants, contracts, cooperative agreements) submitted to the NIH on or after January 25, 2018. Specific to US sites only. Applies to all sites conducting the same protocol. Awardee responsibility: Lead PI must include plan for using single IRB in the proposal/application Effective date: Originally May 25, 2017, recently extended to September 25, 2017. Applicability: For grants, applies to new, competing, resubmissions. Does not apply to career development, research training or fellowship awards. US/foreign sites: If a study will include both US and international sites, the Policy applies to US sites, but foreign sites may use their own IRBs/Ethics Boards. Applies to all sites conducting the same protocol. The NIH has said that the “same research protocol” means protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes. We’re not sure whether that means that the Policy will apply to a site only responsible for conducting data analysis or a site only collecting samples. These types of questions will have to be addressed to the Program Officers as they come up.

NIH Single IRB Policy: Operationalizing at USF If USF is the prime applicant: Currently, USF will cede review of NIH-funded multi-site studies to Western IRB. Proposal must be sent to WIRB at least 2 weeks in advance of submission to USF SR, to allow WIRB to provide estimate for the IRB fees portion of the budget. USF IRB administration assists with coordinating this process.

If USF is a Subrecipient: At proposal: Study teams will need to contact USF IRB administration to discuss whether USF can agree to rely upon the proposed single IRB and to request a letter of support. Obtain info about sIRB fees from the lead site (whether commercial or academic IRB will serve as the sIRB). At award: Study teams will need to contact USF IRB administration to discuss process for entering into a reliance agreement (formal contract via which USF cedes IRB review to an external IRB).

NIH Single IRB Policy: Other Important Information This Policy means fewer IRBs but not less work!

NIH Single IRB Policy: Resources NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research NIH Single IRB Policy FAQs for Extramural Community USF IRB Newsletter, January 2017

Stay tuned . . . The Revised Common Rule includes a provision requiring all federally funded multi-center studies to utilize a single IRB. ***NOTE, however, that the compliance date for this provision is January 20, 2020.

HRPP - Quality Assurance Quality improvement Program Wendy Duncan, RN, BSN, CIP

Objective Provide a brief overview of what the QA/QI Program does currently. Provide an overview of adjustments that will be made after the Revised Common Rule (RCR) is implemented.

QA/QI Program IRB Audits Full study audits includes full IRB audit Full board meeting minute audits Diversified IRB audits: Funding COI ClinicalTrial.gov New staff Exempt/Expedited Amendments/ Reportable Events

2018 QA/QI Efforts Use of consent new elements and summary Initial submissions and consent updates Use of correct category & consistency Documentation of justification: Full continuing review (CR) vs. abbreviated CR Limited IRB review Approval letter language

Quality Assurance – IRB Audits Currently we review a minimum of 20% of key items Our goal will be to review a minimum of 50% of all items impacted by the change and possibly 100% for higher risk items.

Compliance Feedback Monthly review of audits will be reviewed at our noncompliance meeting. Trends and serious issues will be discussed at the Chairs meetings. Feedback will be provided to the board during your IRB full board meetings.

Questions?